Validation on Method of Microbial Limit Test of Povidone Iodine Solution / 中国药房

ABSTRACT

OBJECTIVE:To establish a microbial limit test method for povidone iodine solution.METHODS:Validation on methodology of the microbial limit test of povidone iodine solution was performed using plating method(Ⅰ),culture agent dilution method(Ⅱ),membrane-filter procedure method(Ⅲ)and sodium thiosulfate neutralization in combination with membrane-filter procedure method(Ⅳ).RESULTS:The recovery rates of all of the test organisms in method Ⅰ and method Ⅱ approached zero,less than 70% in method Ⅲ but above 85% in method Ⅳ.The growth of the control bacteria was abnormal in method Ⅱand method Ⅲ,but normal in method Ⅳ.CONCLUSION:It is advisable to adopt the method Ⅳ for microbial limit test of povidone iodine solution.